Childhood Cancer SurvivorsNCT07009288
A Study of Time-Restricted Eating in Childhood Cancer Survivors
A study testing Children's Oncology Group Heart Health Link, Monthly weights and Fasting in people with Childhood Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
This study will look at whether motivational sessions (including regular calls with a trained health coach) in combination with time-restricted eating (TRE) is an effective way to achieve weight loss and lower cardiometabolic risk in adult survivors of childhood cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood Cancer Survivors
- What is being tested?
- Children's Oncology Group Heart Health Link, Monthly weights and Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 May 2025to 1 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in the Childhood Cancer Survivor Study (a cohort of 5+ year survivors of childhood cancer diagnosed at age < 21 between 1970-1999 at 31 participating institutions in North America)
- Are ≥18 years old
- Self-reported body mass index ≥ 25 kg/m2
- Are not pregnant or do not intend to become pregnant in the next year
- Stable weight over the past 3 months (+/- 10 pounds)
- If on oral medication for insulin resistance (ie, metformin), elevated blood pressure, or dyslipidemia, medication dose must be stable (ie, unchanged > 3 months)
- Have internet access (can be via smartphone or computer). If neither device is available, the study can loan participants a Wi-Fi enabled device.
Who cannot join
- Do not reside in the United States
- Do not speak English
- Eating window < 12 hours per 24-hour day
- On insulin or GLP-1 agonist
- Diagnosis of type 1 diabetes mellitus
- Enrolled in a formal weight management program or other weight loss trial
- History of an eating disorder
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chaya Moskowitz, PhD contact
United States4 sites, 4 recruiting
- Recruiting
St. Jude Children's Research Hospital (Data Collection Only)
Memphis, Tennessee, 38105
Gregory Armstrong, MD, 901-595-5892
Gregory Armstrong, MD
- Not yet recruiting
Hunter College
New York, New York, 10065
Jennifer Ford, PhD, 212-396-6690, jennifer.ford@hunter.cuny.edu
Jennifer Ford, PhD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Danielle Friedman, MD, 1-833-MSK-KIDS
Chaya Moskowitz, PhD, 646-227-3607
- Not yet recruiting
Fred Hutchinson Cancer Research Center (Data Collection Only)
Seattle, Washington, 98109
Mary Kwok, MD, rykwok@uw.edu
About this study
Official title: Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study
This study will look at whether motivational sessions (including regular calls with a trained health coach) in combination with time-restricted eating (TRE) is an effective way to achieve weight loss and lower cardiometabolic risk in adult survivors of childhood cancer. The researchers will look at how effective this intervention is compared to the usual approach, which is to review educational materials and measure weight once a month. This study will not provide treatment for any disease or cancer.
- Conditions
- Childhood Cancer Survivors
- Being tested
- Children's Oncology Group Heart Health Link, Monthly weights, Fasting, Calls, Participant Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children's Oncology Group Heart Health LinkOther
Educational materials on healthy lifestyle behaviors.
Monthly weightsOther
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
FastingOther
(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
CallsOther
Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
Participant QuestionnairesOther
Questions on worry, perceived self-efficacy, health beliefs and knowledge of late effects (adapted from EQUAL study), Behavioral Risk Factor Surveillance System, Physical Activity Questionnaire, Link to Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool with accompanying sleep module
Dried blood spotOther
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will be instructed to participate in time-restricted eating, building to a 16-hour fast per day (not eating or drinking calorie-enriched beverages such as soda or nutritional shakes for a 16-hour window, such as 6pm -10am or 7pm-11am). These participants will also receive motivational phone/video calls with a trained health coach, daily text message reminders of when to start and stop their fasting, and monthly weight check-ins. Receives: Other: Monthly weights; Other: Fasting; Other: Calls; Other: Participant Questionnaires; Other: Dried blood spot |
| Control Group | Active comparator | Participants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins. Receives: Other: Children's Oncology Group Heart Health Link; Other: Monthly weights; Other: Dried blood spot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in weight
Measured: at 12 months
Secondary outcomes (3)
Change in glucose
via dried blood spots
Measured: up to 12 months
Change in insulin
via dried blood spots
Measured: up to 12 months
Change in HbA1c
via dried blood spots
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start27 May 2025
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 2b randomized controlled trial of a TRE intervention among childhood cancer survivor participants with overweight and obesity in the Childhood Cancer Survivor Study (CCSS), designed according to the ORBIT model for behavioral intervention development.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Friedman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009288
- Sponsor's protocol ID
- 24-250
- Status last verified
- Sep 2026
- First submitted
- 28 May 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study
- ClinicalTrials.gov ID
- NCT07009288
- Acronym / sponsor ID
- 24-250
- Conditions
- Childhood Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at whether motivational sessions (including regular calls with a trained health coach) in combination with time-restricted eating (TRE) is an effective way to achieve weight loss and lower cardiometabolic risk in adult survivors of childhood cancer. The researchers will look at how effective this intervention is compared to the usual approach, which is to review educational materials and measure weight once a month. This study will not provide treatment for any disease or cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a phase 2b randomized controlled trial of a TRE intervention among childhood cancer survivor participants with overweight and obesity in the Childhood Cancer Survivor Study (CCSS), designed according to the ORBIT model for behavioral intervention development.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Monthly weights, Other: Fasting, Other: Calls, Other: Participant Questionnaires, Other: Dried blood spotParticipants will be instructed to participate in time-restricted eating, building to a 16-hour fast per day (not eating or drinking calorie-enriched beverages such as soda or nutritional shakes for a 16-hour window, such as 6pm -10am or 7pm-11am). These participants will also receive motivational phone/video calls with a trained health coach, daily text message reminders of when to start and stop their fasting, and monthly weight check-ins. |
| Control Group | Active comparator | Other: Children's Oncology Group Heart Health Link, Other: Monthly weights, Other: Dried blood spotParticipants will receive the standard of care electronic handouts through the Way to Health platform, and monthly weight check-ins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrolled in the Childhood Cancer Survivor Study (a cohort of 5+ year survivors of childhood cancer diagnosed at age < 21 between 1970-1999 at 31 participating institutions in North America)
- Are ≥18 years old
- Self-reported body mass index ≥ 25 kg/m2
- Are not pregnant or do not intend to become pregnant in the next year
- Stable weight over the past 3 months (+/- 10 pounds)
Key exclusion criteria (7 listed)
- Do not reside in the United States
- Do not speak English
- Eating window < 12 hours per 24-hour day
- On insulin or GLP-1 agonist
- Diagnosis of type 1 diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Children's Oncology Group Heart Health LinkEducational materials on healthy lifestyle behaviors. | Other | Control Group |
| Monthly weightsWeight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat | Other | Control Group, Intervention Group |
| Fasting(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention) | Other | Intervention Group |
| CallsMonth 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text | Other | Intervention Group |
| Participant QuestionnairesQuestions on worry, perceived self-efficacy, health beliefs and knowledge of late effects (adapted from EQUAL study), Behavioral Risk Factor Surveillance System, Physical Activity Questionnaire, Link to Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool with accompanying sleep module | Other | Intervention Group |
| Dried blood spotGlucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home. | Other | Control Group, Intervention Group |
Primary outcome
Percent change in weight
Time frame: at 12 months
3 secondary outcomes
Change in glucose
Time frame: up to 12 months
Change in insulin
Time frame: up to 12 months
Change in HbA1c
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chaya Moskowitz, PhD contact
Danielle Friedman, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Children's Oncology Group Heart Health Link, Monthly weights and Fasting in people with Childhood Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Friedman, MD (1-833-MSK-KIDS, friedmad@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in weight (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.